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Myo-Inositol and D-Chiro-Inositol for Menstrual Irregularities and Hormone Changes in Women With Polycystic Ovarian Syndrome

NCT07701525 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2026-07-14

No results posted yet for this study

Summary

The goal of this clinical trial is to determine whether a combination of myo-inositol (MI) and D-chiro-inositol (DCI) with folic acid is more effective than placebo (Folic acid alone) in improving menstrual irregularities and hormone levels in women with polycystic ovarian syndrome (PCOS).

The main questions this study aims to answer are:

1. Does treatment with myo-inositol and D-chiro-inositol improve menstrual regularity in women with PCOS compared with placebo?
2. Does the treatment improve biochemical characteristics, including luteinizing hormone (LH), follicle-stimulating hormone (FSH), and testosterone levels, compared with placebo?

Researchers will compare a combination of myo-inositol and D-chiro-inositol with a placebo (folic acid alone) to determine whether the combination therapy is more effective in treating PCOS-related menstrual and hormonal abnormalities.

Participants will:

* Be randomly assigned to receive either a myo-inositol and D-chiro-inositol combination tablet (40:1 ratio) or placebo twice daily for 3 months.
* Have blood samples collected before starting treatment and after 3 months to measure LH, FSH, and testosterone levels.
* Attend monthly follow-up visits during the 3-month treatment period to assess changes in menstrual regularity and monitor their progress.

The study will enroll 60 women aged 18-45 years with PCOS at the Department of Obstetrics and Gynecology, Nishtar Hospital Multan. The results may help determine whether myo-inositol and D-chiro-inositol combination therapy is an effective treatment for improving menstrual function and hormonal abnormalities in women with PCOS.

Conditions

  • Polycystic Ovary Syndrome (PCOS)
  • Myo-inositol
  • D-chiro-inositol

Interventions

DRUG

Myo-Inositol and D-Chiro-Inositol Combination Therapy

Participants will receive an oral combination tablet containing myo-inositol (550 mg), D-chiro-inositol (13.8 mg) in a 40:1 ratio, and folic acid (200 µg), taken twice daily for 3 months.

DRUG

placebo (folic acid)

Participants will receive oral folic acid (200 µg) tablets twice daily for 3 months.

Sponsors & Collaborators

  • Nishtar Medical University

    lead OTHER

Principal Investigators

  • Mehnaz K Professor, FCPS · Nishtar Medical University and Hospital Multan

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-06-01
Primary Completion
2025-11-30
Completion
2025-11-30

Countries

  • Pakistan

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07701525 on ClinicalTrials.gov